MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-12-17 for ABVISER? AUTOVALVE? IAP MONITORING DEVICE ABV331 manufactured by Convatec Inc..
[33830547]
Based on the available information, this event is deemed a reportable malfunction. There were no reports of the patient being harmed as a result of this malfunction. No additional information was available at the time of the report. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[33830548]
It was reported after eight (8) hours in use, the nurse noted that urine was not flowing in the catheter for two(2) hours. A bladder scan was performed and a total of 450cc's of urine was retained in the bladder. As a result, the device was removed and it was discovered that the autovalve did not deflate. The nurse further reported that the catheter drained 450cc's of urine output without issue after removal of the device. A new device was not placed as it was no longer clinically indicated and there was no adverse impact to the patient as a result of the defective device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2015-00721 |
| MDR Report Key | 5307981 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-12-17 |
| Date of Report | 2015-12-02 |
| Date Mfgr Received | 2015-12-02 |
| Date Added to Maude | 2015-12-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABVISER? AUTOVALVE? IAP MONITORING DEVICE |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2015-12-17 |
| Model Number | ABV331 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC INC. |
| Manufacturer Address | 211 AMERICAN AVENUE GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-17 |